Functional characterization is a key step in the characterization and lead selection stage during the mAb therapeutic discovery process. These assays can provide information on the activity, efficacy, and safety of therapeutic mAbs, which can drive the selection of lead molecules for further engineering and optimization.
It is important to note the distinction between the functional activity and binding activity of an antibody. When referring to the function of an antibody, it is often equated with biological activity rather than binding activity. However, screening for antibody function is challenging for many current antibody discovery technologies. Therefore, these platforms often screen for the initial binding activity to identify potential lead molecules for downstream functional characterization.
The binding of an antibody may not always lead to a biological function. However, binding does need to occur for a functional output, as the antibody cannot carry out its MOA without binding to the antigen. Consequently, assessing binding performance is a crucial step in the therapeutic antibody discovery and development pipeline. Please refer to our article, Immunochemical Characterization of Therapeutic Antibodies, for an overview of the immunochemical properties of therapeutic mAbs, including binding performance, and the diverse analytical techniques used in their characterization.